FDA.reportPublic FDA data

NDC 80425-0461-01 - BUPROPION HYDROCHLORIDE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0461
Requested NDC
80425-0461-01
Package NDCs from labels
80425-0461-1, 80425-0461-3, 80425-0461-2, 80425-0461-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BUPROPION HYDROCHLORIDE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0461-1BUPROPION HYDROCHLORIDE30 in 1 BOTTLETABLET, EXTENDED RELEASE301
80425-0461-2BUPROPION HYDROCHLORIDE60 in 1 BOTTLETABLET, EXTENDED RELEASE601
80425-0461-3BUPROPION HYDROCHLORIDE90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0461BUPROPION HYDROCHLORIDE TABLET, EXTENDED RELEASE [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20241222_29a6c6e3-f30f-6541-e063-6394a90ae11d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0461-1EA - Each80425-04616988d166-0241-43ee-9731-510b068ec16412025-02-10
80425-0461-2EA - Each80425-04614a4e3b94-66aa-4ae4-b6bf-9f7c9e64aa3612025-02-10
80425-0461-3EA - Each80425-04615b527564-21a8-4d13-bc93-5e443260613d12025-02-10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 47 · 937 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEMajor Pharmaceuticalsaa3d3e5b-74a3-47f6-b9aa-d6e248e950e52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
rxcui: 993541
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDEAurobindo Pharma Limitedcc344f7c-0eb3-4e63-a09e-b682acca2bb52026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
rxcui: 993541
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.c60855ca-4fa0-4004-ad19-4abb61100c432026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.eb946d81-b4f4-42e9-aa7a-31d76d15629c2026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEREMEDYREPACK INC.740534d3-59b5-4938-8e38-16275a14438c2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDELupin Pharmaceuticals, Inc.1af14d2e-c64d-44b7-a402-8869e8e306612026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
rxcui: 993541
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutions9aa3753f-1a0e-4faa-995f-67e29b3207372026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Bupropion Hydrochloride XLBUPROPION HYDROCHLORIDEA-S Medication Solutionsb2e6c30f-a33c-4854-ab19-bc9f658803742026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993557
unii: ZG7E5POY8O
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
bupropion hydrochlorideBUPROPION HYDROCHLORIDEBryant Ranch Prepacka613cfd3-1aa1-49c5-b742-b105c97d73f12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 993541
unii: ZG7E5POY8O
Bupropion hydrochlorideBUPROPION HYDROCHLORIDECoupler LLC5604eb14-bab4-4f06-e063-6294a90a69202026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
Bupropion HydrochlorideBUPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.867d3876-6974-4e89-bc45-9e60e84b401c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs4fbe64aa-f8f4-45fa-88ae-e844997703ae2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZG7E5POY8O
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.